Associate Medical Director – Rheumatology

About the role

Thermo Fisher Scientific is seeking an Associate Medical Director to provide medical oversight for rheumatology clinical trials. The role bridges scientific expertise and regulatory compliance, ensuring high‑quality data generation that supports innovative therapies.

Key responsibilities

• Oversee all medical aspects of contracted clinical trial tasks across the product life‑cycle.
• Ensure compliance with company SOPs, client directives, Good Clinical Practice (GCP) and ICH guidelines.
• Attend and present at investigator and sponsor meetings, offering medical consultation to clients, investigators and project teams.
• Review and analyze serious adverse events, ICSR, and periodic safety reports (e.g., PBRER, PSUR, DSUR).
• Support the preparation of regulatory deliverables such as labeling reconciliation, CTD modules, REMS, RMP and CSR documents.
• Provide therapeutic and protocol training for study teams as required.
• Assist in business development activities by contributing medical expertise.

Required profile

• Medical degree with board certification in rheumatology.
• Extensive experience in clinical trial oversight and pharmacovigilance.
• Strong knowledge of GCP, ICH guidelines and regulatory safety reporting.
• Proven ability to communicate complex medical information clearly to diverse stakeholders.
• Detail‑oriented with a commitment to data integrity and patient safety.

Required skills

• Good Clinical Practice (GCP)
• ICH guidelines
• Pharmacovigilance
• ICSR analysis
• Periodic safety reporting (PBRER, PSUR, DSUR)
• Clinical trial monitoring
• Regulatory document preparation